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Wound Dressings for Pemphigus and Pemphigoid

Primary Purpose

Pemphigus, Pemphigoid

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cotton gauze with petrolatum
Cellulose acetate with petrolatum
Nanocrystalline silver (Acticoat)
Carboxymethylcellulose with ionic silver (Aquacel Ag)
Sponsored by
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus focused on measuring Pemphigus, Pemphigoid, Wound Healing, Itch, Pain, Wound dressing, Topical treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of pemphigus vulgaris, pemphigus foliaceus , pemphigus vegetans, paraneoplastic pemphigus or bullous pemphigoid
  • At least four areas of active disease in the trunk or limbs of 8 x 8 cm characterized by denudation, ulceration, scabs or blisters.
  • Capable of being evaluated weekly either as outpatient or hospitalized
  • Actively treated with immunosuppressive or immunomodulatory drugs for pemphigus or pemphigoid control
  • Willing to sign an informed consent

Exclusion Criteria:

  • Patients with hypersensitivity to any of the components of the skin dressings that will be used.
  • Patients who have participated in any clinical trial in the last 30 days.

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting
  • Hospital General Dr Manuel Gea GonzálezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cotton gauze with petrolatum

Cellulose acetate with petrolatum

Nanocrystalline silver

Carboxymethylcellulose with ionic silver

Arm Description

The dressing to be used is regular cotton gauze impregnated in petrolatum (a mixture of solid hydrocarbons) creating a film that reduces the adherence of the gauze to the wound.

The dressing to be used is a mesh or tulle base of cellulose acetate polymers that do not easily adhere to the wound impregnated in petrolatum (a mixture of solid hydrocarbons).

The dressing to be used consists of two layers of a silver-coated, high-density polyethylene mesh, enclosing a single layer of an apertured non-woven fabric of rayon and polyester. The three components are ultrasonically welded together to maintain the integrity of the dressing in use. Silver is applied to the polyethylene mesh by a vapour deposition process, which results in the formation of microscopic 'nanocrystals' of metallic silver.

The dressing to be used is a soft, sterile, non- woven pad dressing made from sodium carboxymethylcellulose containing 1.2% silver in an ionic form.

Outcomes

Primary Outcome Measures

Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Percentage of a 64 cm2 area of epithelialized skin

Secondary Outcome Measures

Pain Using the visual analog scale a decrease in pain score
Using the visual analog scale a decrease in pain score
Itch Using the visual analog scale a decrease in itch score
Using the visual analog scale a decrease in itch score

Full Information

First Posted
February 11, 2015
Last Updated
February 18, 2015
Sponsor
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02365675
Brief Title
Wound Dressings for Pemphigus and Pemphigoid
Official Title
An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of four dressings (covers) namely: gauze with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver and nanocrystalline silver to improve the new growth of skin, reduce pain and itch in persons suffering from pemphigus and pemphigoid.
Detailed Description
Pemphigus and pemphigoid are the most frequently autoinmune bullous diseases seen in dermatology. Despite all the treatments that have been studied for the management of bullous skin diseases, there is insufficient information about the best skin dressing or cover that can be used in affected or denuded areas in these conditions. Therefore we will compare the efficacy of four different covers (gauze with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver and nanocrystalline silver) in providing faster healing and decreasing pain and itch. Each patient with the diagnosis of either pemphigus or pemphigoid will have a full skin examination and 4 of the most affected areas will be randomly assigned to receive each of the 4 treatments previously described. There is no clinical study focused specifically on the materials that will be used in this study. There are few isolated cases reported that can not be taken as a basis. Considering the above and based on the clinical experience, we consider it appropriate to conduct a pilot study with a total of 10-14 patients, with it we will perform a sample calculation, considering a potential alpha error of 0.05, yielding the beta error by subtracting 1.0 to the power sample calculated . In all of the patients 4 affected areas of 8 cm x 8 cm ( 64 cm2 ) will be selected and marked with the letters A, B , C and D. The investigator will generate randomization tables where previously established and numbered treatments 1 to 4 will be randomly assigned to each of the four areas. Thus all patients will receive the 4 therapies but randomly in the 4 areas previously selected. The variables that will be studied are: Total area affected : Consists of the sum of the percentages of skin that is not healthy in the 64 cm2 Intensity of pain: sensory unpleasant emotional experience that occurs from the potential or actual injury tissue . Will be assessed by visual analog scale, validated method. Erythema: Inflammation of the skin surface caused by excess blood supply, causing redness. Itch: cutaneous unpleasant sensation and of variable intensity that causes an urge to scratch to get relief. Will be assessed by visual analog scale, validated method. Healing: Reparing process of an altered tissue, resulting in the formation of a scar tissue. Will be measured based on the reduction of wound area percentage. It shall be measured in cm2 with ImageJ® program ( ImageJ® , US National Institutes of Health , Bethesda , Maryland , USA , ( http : //imagej.nih.gov/ij/ ) ) . Ulcer: injury depressed by loss of epidermis, dermis and subcutaneous tissue . They will be measured in total area in cm2 by ImageJ® program. Blisters, pustules or vesicles: are elemental skin lesions with a liquid content ranging from light to heavy white. They will be measured in total area in cm2 by ImageJ® program. Procedure description: Day 0 The patient will be evaluated to determine if is eligible according to the selection criteria. The protocol will be explained in clear words so that the patient understands it. The patient will have to sign the informed consent. Total body surface area will be revalutatd to select the 4 most severely affected areas in the trunk or limbs of 8 cm x 8 cm each and that will be assigned with a letter from A to D. With an indelible marker the 4 vertices of each of the previously selected areas will be marked. A label graduated in millimeters will be placed at the bottom edge of the marked areas. A panoramic picture of each of the four areas will be taken to ensure that if the label is lost, we can replicate it in the next visit. An aproach picture of each of these four areas will be taken. The selected areas will be cleaned with sterile saline. Clinical evaluation will be performed and the section of the report format will be filled. The envelope containing randomization numbers will be opened to decide which dressing skin cover will be used to each of the selected areas. The dressings (covers) will be placed on each of the selected areas. Above it conventional gauze will be placed and this cure will be pinned up with conventional elastic white band. The patient will recieve the appointments of the 6 subsequent valorations. The patient will recive the prescription for the systemic management of the bullous skin disease. The patient will receive a second prescription explaining how he should be healing between each visit. If it is an inpatient, the healing and measurement will be performed by the medical personnel assigned. The family will be explained how to perform the healing and at the end of his hospital stay a prescription will be given with the instructions. Also the next control appointment will be given. Pictures will be downloaded and the presence of abnormal skin will be measured using a standardized measurement program ( ImageJ® , US NationalInstitutes of Health , Bethesda , Maryland , USA , ( http://imagej.nih.gov/ij/ ) ). All data obtained will be registered in the report format made specifically for this trial. Subsequent visits ( 7, 14, 21 , 28, 35 ) The presence of systemic or local adverse effects at any of the 4 areas of study will be asked. The 4 areas will be discovered using saline and gently drying. The healling and the further steps are the same as the ones explained above. All the data obtained will be recorded on the report format. Final visit (day 42) The patient will be told he or she is no more in the protocol and which of the dressings worked the best. The patient will receive his or her next appoinment. A prescription with the systemic treatment will be given. A second prescription will be given, explaining how to perform the healings. All data obtained will be recorded to the further results analysis. Results will be presented as percentages or proportions for categorical variables and by mean ± standard deviation for continuous variables. The percentage of epithelialization between the four groups will be compared with Chi Square RxC. Continuous numerical variables will be compared with one way ANOVA in the case of homoscedastic variances or by Kruskall Wallis variance in the case of heteroskedastic variances. The results will be adjusted in relation to the received systemic treatment (duration, intensity), the location of the lesions and its chronicity with multivariate lienal regression analysis . For bivariate anaysis a significant value of p < 0.05 will be used. For multivariate analysis a p < 0.10 value will be used. STATA version 13.0 for Mac wiil be used. Tables and grapfhs will be used to present the results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus, Pemphigoid
Keywords
Pemphigus, Pemphigoid, Wound Healing, Itch, Pain, Wound dressing, Topical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cotton gauze with petrolatum
Arm Type
Active Comparator
Arm Description
The dressing to be used is regular cotton gauze impregnated in petrolatum (a mixture of solid hydrocarbons) creating a film that reduces the adherence of the gauze to the wound.
Arm Title
Cellulose acetate with petrolatum
Arm Type
Active Comparator
Arm Description
The dressing to be used is a mesh or tulle base of cellulose acetate polymers that do not easily adhere to the wound impregnated in petrolatum (a mixture of solid hydrocarbons).
Arm Title
Nanocrystalline silver
Arm Type
Active Comparator
Arm Description
The dressing to be used consists of two layers of a silver-coated, high-density polyethylene mesh, enclosing a single layer of an apertured non-woven fabric of rayon and polyester. The three components are ultrasonically welded together to maintain the integrity of the dressing in use. Silver is applied to the polyethylene mesh by a vapour deposition process, which results in the formation of microscopic 'nanocrystals' of metallic silver.
Arm Title
Carboxymethylcellulose with ionic silver
Arm Type
Active Comparator
Arm Description
The dressing to be used is a soft, sterile, non- woven pad dressing made from sodium carboxymethylcellulose containing 1.2% silver in an ionic form.
Intervention Type
Device
Intervention Name(s)
Cotton gauze with petrolatum
Intervention Type
Device
Intervention Name(s)
Cellulose acetate with petrolatum
Other Intervention Name(s)
Curity non-adhering dressing
Intervention Type
Device
Intervention Name(s)
Nanocrystalline silver (Acticoat)
Other Intervention Name(s)
Acticoat
Intervention Type
Device
Intervention Name(s)
Carboxymethylcellulose with ionic silver (Aquacel Ag)
Other Intervention Name(s)
Aquacel Ag
Primary Outcome Measure Information:
Title
Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Description
Percentage of a 64 cm2 area of epithelialized skin
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Pain Using the visual analog scale a decrease in pain score
Description
Using the visual analog scale a decrease in pain score
Time Frame
42 days
Title
Itch Using the visual analog scale a decrease in itch score
Description
Using the visual analog scale a decrease in itch score
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of pemphigus vulgaris, pemphigus foliaceus , pemphigus vegetans, paraneoplastic pemphigus or bullous pemphigoid At least four areas of active disease in the trunk or limbs of 8 x 8 cm characterized by denudation, ulceration, scabs or blisters. Capable of being evaluated weekly either as outpatient or hospitalized Actively treated with immunosuppressive or immunomodulatory drugs for pemphigus or pemphigoid control Willing to sign an informed consent Exclusion Criteria: Patients with hypersensitivity to any of the components of the skin dressings that will be used. Patients who have participated in any clinical trial in the last 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Contreras-Ruiz, MD
Phone
+525540003000
Ext
3502
Email
dermayheridas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Lopez-Ortiz, MD
Phone
+5215585583329
Email
karlitaav24@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Contreras-Ruiz, MD
Organizational Affiliation
Hospital General Dr Manuel Gea Gonzalez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Dominguez-Cherit, MD
Phone
+525554870900
Ext
4586
Email
judom59@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rodrigo Cepeda, MD
Phone
+525554870900
Ext
4586
Email
dr.rcepeda@gmail.com
Facility Name
Hospital General Dr Manuel Gea González
City
Mexico
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Contreras-Ruiz, MD
Phone
+525540003000
Ext
3502
Email
dermayheridas@gmail.com
First Name & Middle Initial & Last Name & Degree
Karla Lopez-Ortiz, MD
Phone
+5215585583329
Email
karlitaav24@hotmail.com

12. IPD Sharing Statement

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Wound Dressings for Pemphigus and Pemphigoid

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